Phase 2 Haemophilia Trial, Recruiting NCT04676048 Sponsor: ASC Therapeutics Condition: Haemophilia
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Phase 2 Haemophilia Trial, Recruiting

NCT04676048
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are male and at least 18 years old
  • You have been diagnosed with severe or moderately severe hemophilia A, confirmed by your medical history
  • You have received treatment (either regular preventive or as-needed) for hemophilia A on at least 150 separate days
  • If you use as-needed (not regular) treatment, you have had at least 12 bleeding episodes in the past 12 months
  • Your body mass index (a measure of body weight relative to height) is 30 or below
  • You are willing to use two forms of contraception until at least 3 consecutive sperm samples test negative after receiving the study treatment

Who may not be able to join:

  • You have pre-existing immunity to a specific virus used to deliver the treatment (called AAV8), detected by blood tests
  • You currently have, or have a history of, high levels of antibodies that block the clotting factor used to treat hemophilia A (called inhibitors)
  • You have moderate-to-severe liver scarring, detected by a liver scan
  • You have a history of long-term kidney disease
  • You currently have an active infection or a condition that affects your immune system
  • You have had heart surgery and need blood-thinning medication
  • You have any heart-related or genetic risk factors that increase your chances of developing blood clots (confirm with trial site)
  • You currently have an active infection with Hepatitis B, Hepatitis C, HIV-1/2, or syphilis
  • You have previously received any gene therapy or similar treatment
  • You are currently taking antiviral medication for Hepatitis B or C

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: (408) 495-3891

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
ASC Therapeutics
Registry
ClinicalTrials.gov
Start date
3 August 2022
Est. completion
1 December 2023

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of adverse events, and serious AEs

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov